← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K960569

# DISPOSABLE PATIENT RETURN ELECTRODE (K960569)

_Erbe USA, Inc. · GEI · Mar 11, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960569

## Device Facts

- **Applicant:** Erbe USA, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Mar 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.

## Device Story

Disposable patient return electrode; functions as grounding pad for high-frequency (HF) electrosurgical current; completes electrical circuit between patient and electrosurgical generator; prevents thermal injury at return site; used in surgical settings; operated by surgeons or surgical staff; compatible with Erbe and third-party electrosurgical generators; available with or without pre-attached cable; utilizes established materials and technology consistent with existing market devices.

## Clinical Evidence

No clinical data provided. Safety and effectiveness based on established technology and materials used in existing market devices.

## Technological Characteristics

Disposable conductive electrode pad; adhesive interface for patient skin contact; optional pre-attached cable; compatible with standard HF electrosurgical generators; passive electrical component.

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Predicate Devices

- ConMed Disposable Return Electrodes

## Submission Summary (Full Text)

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K960569

510(k) Notification ERBE Disposable Patient Return Electrode

February 2, 1996

MAR 11 1996

# Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. ERBE has been working intensively during this entire period in the production and distribution of state-of-the-art HF surgical instruments and accessories. The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.

The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable.

Disposable return electrodes have been manufactured and distributed worldwide by ConMed and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials

It is Erbe's intention to apply for ISO Registration and market this product under the CE mark. It is Erbe policy that all product marketed under the Erbe name are so registered.

Based upon the documents enclosed in this Notification, we believe the ERBE Disposable Patient Return Electrodes are Safe and Effective for their intended purpose when used in accordance with the Instructions for Use.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960569](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K960569)

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